Decisions to treat or not to treat pneumonia in demented psychogeriatric nursing home patients: development of a guideline

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1 Journal of Medical Ethics 2000;26: Decisions to treat or not to treat pneumonia in demented psychogeriatric nursing home patients: development of a guideline Jenny T van der Steen, Martien T Muller, Marcel E Ooms, Gerrit van der Wal and Miel W Ribbe Vrije Universiteit, Amsterdam and Nursing Home Naarderheem, Bussum, the Netherlands Abstract Non-treatment decisions concerning demented patients are complex: in addition to issues concerning the health of patients, ethical and legal issues are involved. This paper describes a method for the development of a guideline that clarifies the steps to be taken in the decision making process whether to forgo curative treatment of pneumonia in psychogeriatric nursing home patients. The method of development consisted of seven steps. Step 1 was a literature study from which ethical, juridical and medical factors concerning the patient s health and prognosis were identified. In step 2, a questionnaire was sent to 26 nursing home physicians to determine the relative importance of these factors in clinical practice. In a meeting of nine experienced physicians (step 3), the factors identified in step 2 were confirmed by most of these professionals. To prevent the final guideline being too directive, a concept guideline that included ethical and legal aspects was designed in the form of a checklist of considerations (step 4). Experts in the fields of nursing home medicine, ethics and law reviewed and commented on the concept guideline (step 5). The accordingly adapted checklist of considerations was tested in a pilot study (step 6), after which all experts endorsed the checklist (step 7). The resulting checklist of considerations structures the decision making process according to three primary domains: medical aspects, patient s autonomy, and patient s best interest (see annex at end of paper). (Journal of Medical Ethics 2000;26: ) Keywords: Decision making; medical futility; patient advocacy; pneumonia; practice guidelines; nursing homes Introduction Physicians involved in the care of elderly patients with a limited life expectancy are often confronted with the dilemma of whether treatment should be given or should be considered inevective or undesirable. Decision making is particularly complicated with regard to incompetent patients, for example in the case of resuscitation and hospitalisation. This problem is paramount when considering the administration of antibiotics to demented nursing home patients with pneumonia. 1 Curative treatment, which is aimed at achieving cure of the pneumonia, does not necessarily result in an improvement in physical or mental health status. However, refraining from curative treatment and providing only palliative treatment, solely aimed at alleviating symptoms to improve the patient s wellbeing, could imply that death is hastened. However, in addition to the medical considerations mentioned above, ethical and legal issues are involved as well, which further complicates the decision making process. In general, guidelines can be a support by systematically addressing the various aspects involved in the decision making process. Medical guidelines, especially when evidence-based, can be quite directive. However, when juridical and especially ethical factors are to be considered as well, the good decision is not always as clear cut. The physician has to balance the relative importance of many, possibly conflicting, considerations to come to a decision. Therefore, the requirements for this type of guideline are quite diverent from the requirements for the traditional medical guidelines. This paper describes a method of constructing guidelines for decision making concerning demented nursing home patients. This method was used to develop a guideline for do-not-treat decisions in nursing home patients with pneumonia. Pneumonia was chosen because of its high incidence in nursing home patients, and the associated high morbidity and mortality rates. 2 5 An outline of the checklist of considerations is presented in the annex, and a slightly adapted front page in table 1.

2 Table 1 Slightly adapted version of the front page of the checklist of considerations EMGO/HVSG Vrije Universiteit, Amsterdam Points to consider in the decision process for starting or not starting a curative treatment of pneumonia in psychogeriatric patients Instruction The list has been constructed as a questionnaire. Every section ends with a concluding question, after which is included a block with explanatory text, which refers to a part of, or all answer categories. Hereafter one is led to the next section which is applicable to this patient. The last page but one consists of a summarizing survey (section D), which one should fill out to visualize the main considerations on one page to be of use for the decision process. The purpose of this list of points to consider is to assist nursing home physicians in the decision process for starting or not starting a curative treatment of pneumonia in psychogeriatric nursing home patients. The list is not designed to direct the physician to a certain treatment decision. Structuring the decision process is done by carefully and systematically recording some medical aspects, and especially the aspects that are important to consider in the decision process from a legal and ethical point of view. Naturally, in all cases the responsibility for the final decision lies in the hands of the responsible treating physician. The main guiding variables in the decision process are: 1. the expected evect of a curative treatment from the medical perspective; 2. the patient s wish: a living will, or the reconstruction of the wish; 3. the patient s best interest in case the wish of the patient is not clear, or remains unknown. Definitions Experts (Intentionally) curative treatment of pneumonia: The following experts have commented on the list of points to a treatment of pneumonia that has achieving cure as the primary goal. consider, and have subsequently subscribed to the list: Explanation: this is irrespective of the chance of success of curing J J M van Delden, MD, PhD (the Netherlands) pneumonia. The treatment consists of antibiotics, which can be Prof H M Dupuis, PhD (the Netherlands) combined with (re)hydration. Nevertheless, the course of the disease L Emanuel, MD, PhD (USA) may necessitate installing palliative treatment as well. C M P M Hertogh, MD, PhD (the Netherlands) Palliative treatment of pneumonia: A Hoogerwerf, MD (the Netherlands) a treatment whose primary goal is not cure, but is aimed at treating the Prof H Kuhse, PhD, (Australia) symptoms of the pneumonia. Explanation: the aim of this is to improve the patient s wellbeing and quality of life. Palliative use of antibiotics - when achieving cure is not the primary goal - can be meant by this as well. Methods STEP 1: STUDY OF LITERATURE The Medline database was used to search the medical literature from 1987 to 1994, for papers dealing with prognostic factors and other possible factors that can play a role in the decision making process about whether to treat pneumonia or other infections curatively. Only those studies were selected in which at least some of the participants were psychogeriatric nursing home patients. The bibliographies of all the papers identified were reviewed, as well as the indices ( ) of relevant journals that were not included in the Medline database. The literature search was repeated twice during the whole process in order to identify more recent literature. STEP 2: INFORMATION FROM CLINICAL PRACTICE The aim of this step was: a) to examine the relative importance in clinical practice of the medical, juridical and ethical factors identified in the literature search, and b) to identify additional factors which could be considered important. For this purpose, a questionnaire was designed and sent to a jury of 26 nursing home physicians (NHPs) who had experience in nursing home medical practice and were associated with the Prof H D C Roscam Abbing, LLD (the Netherlands) Prof J M Stanley (USA) This list with points to consider has been autorized by the Dutch Society for Nursing Home Physicians (NVVA) for the present, on behalf of the Pneumonia Study. EMGO-Institute August 1997 Van der Steen, Muller, Ooms, et al 115 university. The questionnaire was anonymous. Table 2 shows the topics that were addressed. STEP 3: CONSENSUS MEETING OF MEDICAL PROFESSIONALS A meeting of nine experienced NHPs was held to investigate the need for this specific guideline and to reach consensus about the factors (medical, ethical, juridical and also procedural aspects) to be included in such a guideline, based on the results of the literature search and the questionnaire, as well as their expert opinion. In addition, how certain they were about the decision being the right one was discussed. STEP 4: DESIGN OF A CONCEPT GUIDELINE As information and consensus on the medical factors determining the usefulness of curative treatment for pneumonia were lacking, it was decided to develop a checklist of considerations, based mainly on ethical and juridical issues. Medical issues were addressed in general terms only. STEP 5: CONSULTATION OF (INTER)NATIONAL EXPERTS To ensure widespread support for the checklist of considerations, five national and three

3 116 Decisions to treat or not to treat pneumonia in demented psychogeriatric nursing home patients: development of a guideline Table 2 Topics addressed and form of questions on the questionnaire for nursing home physicians on important factors for the decision to treat or not to treat pneumonia curatively in psychogeriatric patients (step 2) Topic Form of questions Analysis 1. The individual value that is attached to factors concerning the patient s health status 2. Factors considered important but not included under 1 3. The importance and role of family or other representatives of the patient in the decision making process 4. The importance and role of the nursing stav in the decision making process 5. Decisive status (ie importance for the outcome of the decision) of the already mentioned factors international experts in the fields of nursing home medicine, ethics and law were consulted. They were sent the conceptual, that is to say, the initial checklist of considerations, and a questionnaire containing questions about their agreement or disagreement with each separate section of the list and the usefulness of the checklist as a whole. The experts were asked to state the reason for any disagreements and to suggest alternatives. STEP 6: PILOT STUDY Subsequently, a pilot study was performed to detect potential misinterpretation of the text and to evaluate the practical applicability of the checklist. Five nursing home physicians were asked to use the checklist either for two consecutive patients for whom they made a decision as to whether to treat pneumonia curatively, or else to complete it for two previous cases. STEP 7: APPROVAL AND AUTHORISATION In order to obtain a high level of professional acceptance, the checklist of considerations was submitted to the international experts of step 5 for approval. Partial approval or approval with specific individual comments, was also an option. Finally, in order to obtain the status of a national guideline, the Dutch Society for Nursing Home Physicians (NVVA) was asked to authorise the checklist of considerations. Results The literature review identified reports and a discussion paper, 6 as well as many opinionative articles potentially related to withholding curative treatment in psychogeriatric nursing home patients. Besides these, Dutch reports from leading societies on the acceptability of terminating life in incompetent patients were identified 7 10 along with the national Dutch Law on the Medical Treatment Agreement (1995). Factors concerning health status and prognosis that could play a role in the a list of factors with a 5-point scale to rate the importance of the factor open-ended question with a 3-point scale to rate the importance of the factor set of pre-structured questions set of pre-structured questions list of factors rated for importance on an interval scale from 0 (unimportant) to 10 (important) calculation of a mean value, median value and mode of each item decision making process were reported on in numerous studies of community-acquired pneumonia in adult hospitalised patients; these were reviewed in a meta-analysis in 1996 by Fine et al. 11 Prognostic information concerning treatment of patients with fever or lower respiratory tract infections 15 in demented (nursing home) patients was available, but not specifically for pneumonia patients. Specific guidelines for seriously demented patients appeared to be available neither in the Netherlands, nor elsewhere. However, the need to implement standards for decision making in the care of severely demented patients was confirmed by several authors Repetition of the literature search did not deliver any specific guideline on whether to treat pneumonia curatively in elderly patients. Recently, a report was published on the treatment of elderly pneumonia patients concerning, however, mainly hospitalised patients. 19 Two recent studies on pneumonia mortality in nursing home patients treated with antibiotics did reveal some prognostic factors which are directly relevant to the checklist of considerations. The results of the questionnaire on clinical practice (step 2) are presented in table 3. Twenty NHPs (77%) responded. Almost all respondents (95%) rated the overall physical condition of the patient important or very important when making the treatment decision. The estimated life expectancy (75%), active or passive communication skills (60%), and the severity of dementia (60%) were considered either very important or important factors by most of the responding NHPs as well. When asked about important somatic factors that were not mentioned in the questionnaire, the NHPs gave a wide variety of answers. Most frequently mentioned (n = 6) was the patient s wellbeing, also described as mood or will to live, before the onset of pneumonia. Sixteen additional factors were mentioned, most of them related to the patient s prognosis or suvering. According to 55% of the NHPs, contact

4 Table 3 The value attributed to medical factors concerning the patient s health status (table 2, topic 1) when making treatment decisions concerning psychogeriatric patients with pneumonia, as rated by 20 nursing home physicians (NHPs) Medical factors with the family of the patients (topic 3 in table 2) should always take place the moment pneumonia occurs. DiVerent reasons were given for this: reconstructing the wish of the patient, asking for the family s opinion on the best treatment, or merely informing them about the treatment decision. According to the remaining 45% of the NHPs, contact with the family was not always necessary, mainly when the patient s wish was already known, or when the family was not involved with the patient. All NHPs, however, were of the opinion that contact with the nursing stav should always take place. For this purpose, the same reasons as with contact with the family were mentioned. Less significance, however, was given to the role of the nursing stav in reconstructing the patient s wish (15% for nursing stav, versus 35% for the family). As far as decisive factors are concerned, the highest scores for the degree of importance (median score 9 on a 10-point scale) were given to the items the patient s health prior to the onset of pneumonia, medical sense/futility to treat (non-)curatively, and the previously expressed wish of the patient to be treated curatively. The expected physical health status of the patient in case of cure (prognosis) ranked fourth. Items with median and mode scores less than nine included the wish of the family and of the nursing stav to treat the patient curatively, the severity of dementia and success achieved by curative treatment of pneumonia in the past. Least important, according to most of the NHPs (mode 0), were comorbidity and the burden on the patient due to the treatment, or the burden on the patient due to the pneumonia itself. The participating experienced professionals consulted during the consensus meeting (step 3) reported that the results of the questionnaire were on the whole in accordance with their concept of clinical practice. The professionals agreed that if no explicit wish had been expressed, the patient s physical condition before the onset of pneumonia Degree of importance (% of NHPs) 1(very unimportant) 2 (unimportant) 3 (slightly important) 4 (important) Overall physical health status Estimated life expectancy Communication skills (active and passive)* Severity of dementia Pressure ulcers Mobility ADL Incontinence *1 NHP did not answer this question. Van der Steen, Muller, Ooms, et al 117 5(very important) was the most important criterion for determining whether or not to treat the patient curatively. There was no consensus, however, on which specific aspects of the patient s physical condition should be considered (for example, ongoing weight-loss, insuycient fluid intake, etc). In general, the (reconstructed) wish of the patient was considered to be very important, though not always decisive. The wish of the family (ie not the reconstructed wish of the patient) and the opinion of the nursing stav could be considered in decision making, but should never be decisive. Nevertheless, the more a physician was in doubt, the more the opinion of family and nursing stav was taken into account. Predicting the outcome of a specific treatment for an individual patient was considered to be very diycult, although some professionals were reasonably confident that their estimates were usually accurate when prognostic factors such as the degree of dyspnoea, the presence of tachypnoea and the intake of fluids were taken into account. The necessity for a guideline concerning nontreatment decisions to do with pneumonia in demented nursing home patients was fully confirmed by six of the nine professionals. Of the remaining three, only one did not feel the need for any support by means of a guideline. For the next step (step 4), the project group decided to construct the guideline in the form of a checklist of considerations. A guideline in the form of a traditional protocol was considered to be too directive. The checklist was based on the results of the first three steps. A front-page (table 1) was added, explaining the origin, purpose, structure and definitions. In the next step (step 5), all the invited experts agreed to take part in the expert panel and gave their comments on the first concept. The only major adaptation was made for the section medical aspects. This section was cleared of ethical aspects, which were moved to a new best interest section. Possible harmful medical evects,

5 118 Decisions to treat or not to treat pneumonia in demented psychogeriatric nursing home patients: development of a guideline ie the burden of treatment, were separated from other medical aspects. Some questions were reformulated to prevent biasing the physician. As a result of the pilot study (step 6), further adaptations were made. The main adaptation concerned the summary, which until then determined the routing of the checklist. This proved to be impractical and confusing. The summary was made optional, for example one could give a short overview of a complex case. In step 7, all the experts who were consulted in step 5 now approved of the checklist of considerations as a whole, though some of the experts still required minor (mainly textual) adaptations. Subsequently, the Dutch Society for Nursing Home Physicians (NVVA) granted authorisation for use of the checklist in an evaluation study. Discussion With the method described above, it proved to be possible to develop a nationally and internationally approved checklist of considerations for end-of-life decisions in psychogeriatric patients, ie the decision whether or not to treat pneumonia curatively. Though timeconsuming it took three years to develop the complete checklist the method guarantees input from the literature and the nursing home profession, as well as input from experts in other disciplines. Widespread support was obtained from renowned experts, as well as from the Dutch Society for Nursing Home Physicians, which will greatly enhance the acceptance of the guideline. It has been widely accepted that physicians should be guided by four ethical principles: respect for autonomy, doing good, doing no harm, and justice. In daily practice, medical decision making is mainly guided by medical considerations. This is confirmed by the results of the questionnaire and the meeting of professionals, and is reflected in the checklist of considerations, as medical evectiveness of the treatment is required and is considered first (doing good and doing no harm). However, information from the literature on prognostic factors was scarce and of poor quality, and, moreover, no consensus could be reached on these medical prognostic factors. Therefore, this aspect had to be presented in general terms, so that a physician could make his/her own judgment. The second main point of the checklist of considerations is the patient s wish. Most NHPs and professionals thought the wish of the patient expressed when the patient was still competent was important, though medical considerations prevailed, according to the questionnaire and the meeting of professionals. Of course, the patient s wish should be respected (autonomy). Most psychogeriatric patients, however, can no longer grasp the consequences of their decision, or are incapable of communicating their wishes. When direct information about the wish of the patient is not available, the family or representative should be asked to reconstruct the patient s wish. Though the wish of the family itself was not regarded as decisive, most of the NHPs and experts agreed that the family should be involved in the decision making process. The position of the nursing stav was also thought to be important. The fourth principle, justice, is implicitly reflected in the checklist: only costs and benefits for the individual, and not for the community, are at stake. In order to make a decision based on ethical principles, information about the patient characteristics that determine the course and consequences of pneumonia is also necessary. As these characteristics are still largely unknown, both the physician and the family are compelled to give their personal opinion of what is in the patient s best interest when the patient s wish is unknown. This constitutes the third main point on the checklist of considerations. Although the checklist of considerations has been developed for use by NHPs in the Netherlands, and for the specific decision about whether to treat pneumonia curatively in psychogeriatric patients, the problem addressed here is universal. Thus, the method may very well be applicable for developing guidelines to cover the broader scope of non-treatment decisions in incompetent patients. It took a long time to complete the development process, mainly due to the many refinements that had to be made. As these pitfalls can now be avoided, we are confident that developing a new guideline according to this method will be much less time-consuming. According to the nature and extent of the underlying evidence and international variations in law, the process of developing guidelines might need to be adapted for each end-of-life decision. If the literature does not provide suycient basis for guideline formulation, other sources of information can be used (expert opinion, extrapolation of the results of studies with a diverent population, analysis of routinely collected data). 22 The information provided by the ultimate users of the checklist of considerations, ie NHPs, is especially important in terms of the applicability and acceptability of the guideline. The relative weight of each prognostic factor will be evaluated in a subsequent prospective study, designed to produce data on prognosis (chance of cure, quality of life) of both curatively and palliatively treated patients. The resulting indicators for the prognosis will be included in the

6 checklist of considerations. Rigorous evaluation is needed to investigate the actual evect of guidelines on practice. 23 Meanwhile, we have investigated the acceptance of the contents, and the Annex Summarising survey of the checklist of considerations applicability of the checklist of considerations in practice. A further paper, evaluating the checklist of considerations is currently submitted for publication. Copy the results of the preceding pages, as far as applicable. Completing the summary is optional. A.1.6 Is an intentionally curative treatment indicated for this patient? h yes, indicated h I don t know h no, not indicated A physician is not compelled to act if this is not medically evective. Moreover, a request to treat can not be honoured if the treatment at issue is not in agreement with the medical professional standards. According to - among others - CAL, 78 starting a treatment is undesirable if it is considered to be not medically evective, irrespective the wishes and opinions of the patient and other persons involved. There should be a dialogue, however, with the nursing stav and the patient s representative(s), explaning the undesirability of installing treatment which is not evective. A.2.3 How physically and/or psychically burdensome would the total curative treatment - antibiotics and (re)hydration - be for the patient? h very burdensome h somewhat burdensome h not or little burdensome When choosing the best treatment, beside the medical evectivity, the burden of treatment plays a part. B.1.4 Is the patient suyciently mentally competent, and if so, what treatment does the patient want? h insuyciently competent h suyciently competent, wants curative treatment h suyciently competent, wants palliative treatment In this situation, merely the present wish of the patient applies and the rules for informed consent must be adhered to. Neither a living will, nor family nor representative(s) play a role in the decision process. B.2.9 What is the purport of the living will? h unclear/absent h patient wants curative treatment h patient wants palliative treatment In the WGBO(Dutch law) a negative living will has been given a legal status. A physician is compelled to follow the will when the patient does not wish a curative treatment, unless there are suycient grounds (as mentioned in B.2.5 B.2.8) not to do so. As a rule, there should be a dialogue with the nursing stav and the patient s representative(s). The living will, however, is decisive. B.3.9 What is the purport of the reconstruction of the patient s will according to the representative(s)? h absent/doubt/opposing opinions h intentionally curative treatment h palliative treatment According to the WGBO, appointed as well as unappointed representatives have the authority to take decisions on the patient s behalf. The physician, however, retains his or her responsibility to test these decisions for medical evectiveness, and whether the representatives are actually reconstructing the wish of the patient (which has been tested in part B.3). B.4.7 What is the purport of the reconstructed patient s wish according to the other involved professional carers? h doubt/opposing opinions h intentionally curative treatment h palliative treatment The nursing stav and other (para)medics are not authorized to make decisions. The treating physician retains this responsibility. C.5 Which treatment seems to be in the patient s best interest? h doubt/opposing opinions h intentionally curative treatment h palliative treatment Finally, the physician bases his or her choice of the treatment on what is in the patient s best interest. EMGO-Institute 1997 Van der Steen, Muller, Ooms, et al 119 J Med Ethics: first published as /jme on 1 April Downloaded from Acknowledgements We wish to thank A van Bemmel, MD; J F J M van Berkel, MD; V G M Chel, MD; W Deerenberg-Kessler, MD; J J M van Delden, MD, PhD; C M P M Hertogh, MD, PhD; J F Hoek, MD; P van Houten, MD; J van Willigen, MD, all of whom are nursing home physicians, for participating in the consensus meeting. The valuable and often time-consuming contributions of the national and international experts as mentioned in table 1 are highly appreciated. We thank the Board of the Dutch Society for Nursing Home Physicians (NVVA) and G L Schut, MD, PhD, Chairman of the Quality Committee, for their work on the authorisation of the guideline and Ellen Kampers for her administrative work. Funding The study is funded by the Dutch Ministry of Public Health, Welfare and Sports (VWS). The pilot study was funded by Society Het Zonnehuis. Jenny T van der Steen, MSc, is an Epidemiologist and Principal Researcher on the Pneumonia Study which has two main goals: identification of prognostic factors for pneumonia in psychogeriatric nursing home patients, and development and evaluation of the checklist of considerations. In 1995/96 she performed a pilot study; in July 1996 she was appointed as a PhD student in the Institute for Research in Extramural Medicine (EMGO-Institute) of the Vrije Universiteit, Amsterdam, the Netherlands, to continue with her main study on pneumonia. Data collection for on 17 October 2018 by guest. Protected by copyright.

7 120 Decisions to treat or not to treat pneumonia in demented psychogeriatric nursing home patients: development of a guideline the main study was carried out in 61 nursing homes in the Netherlands. Martien T Muller, PhD, is a Social Gerontologist in the Department of General Practice, Nursing Home Medicine and Social Medicine of the Vrije Universiteit. He also works as a Social Gerontologist at the Nursing Home, Naarderheem, Bussum, the Netherlands. He is a member of the project group of the Pneumonia Study. Marcel E Ooms, MD, PhD, is Project Leader of the Pneumonia Study and is Epidemiologist and Senior Researcher in the Department of General Practice, Nursing Home Medicine and Social Medicine of the Vrije Universiteit. Gerrit van der Wal, MD, PhD, is Professor of Social Medicine in the Department of General Practice, Nursing Home Medicine and Social Medicine of the Vrije Universiteit. He is also a member of the project group of the Pneumonia Study. 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